Recall Z-2311-2021 ยท NJT Immunohistochemistry Reagents And Kits
Cell Marque Corporation
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
| Date | Jul 15, 2021 |
| Status | Open, Classified |
| Reason | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest. |
| Root cause | Incorrect or no expiration date |
| Action | On 07/15/2021, recall notifications were mailed to consignees. Consignees were asked to do the following: Forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. In addition, if the affected product was further distributed, notify the associated customers of this issue and forward a copy of this recall notification. Examine your inventory to determine if you have any remaining Affected Product and quarantine from further use. Destroy any unused or partially used containers of the Affected Products rendering th |
| Quantity | 20 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.